Zhuang Yan, Sheets Lincoln R, Shae Zonyin, Chen Yin-Wu, Tsai Jeffrey J P, Shyu Chi-Ren
Infomatics Institute.
School of Medicine, University of Missouri, Columbia, MO, USA.
AMIA Annu Symp Proc. 2020 Mar 4;2019:1276-1285. eCollection 2019.
Patient recruitment for clinical trials is known to be a challenging aspect of clinical research. There are multiple competing concerns from the sponsor, patient and principal investigator's perspectives resulting in most clinical trials not meeting recruitment requirements on time. Conducting under-enrolled clinical trials affects the power of conclusive results or causes premature trial termination. The Blockchain is a distributed ledger technology originally applied in the financial sector. Its features as a peer-to-peer system with publicly audited transactions, data security, and patient privacy are a good fit for the needs of clinical trials recruitment. The "Smart Contract" is a programmable self-executing protocol that regulates the blockchain transactions. Given current recruitment challenges, we have proposed a blockchain model containing multiple trial-based contracts for trial management and patient engagement and a master smart contract for automated subject matching, patient recruitment, and trial-based contracts management.
临床试验的患者招募是临床研究中一个具有挑战性的方面。从申办方、患者和主要研究者的角度来看，存在多个相互竞争的问题，导致大多数临床试验无法按时达到招募要求。进行入组人数不足的临床试验会影响确定性结果的效力，或导致试验提前终止。区块链是一种最初应用于金融领域的分布式账本技术。其作为一个具有公开审计交易、数据安全和患者隐私的对等系统的特性，非常适合临床试验招募的需求。“智能合约”是一种可编程的自执行协议，用于管理区块链交易。鉴于当前的招募挑战，我们提出了一种区块链模型，该模型包含多个用于试验管理和患者参与的基于试验的合同，以及一个用于自动受试者匹配、患者招募和基于试验的合同管理的主智能合约。
